Transvaginal surgical mesh implants (or ‘slings’) used to repair pelvic organ proplase (POP) and stress urinary incontinence (SUI), have been linked to a high rate of serious mesh complications.
On August 25, the consumer advocacy group Public Citizen addressed a petition to the FDA commissioner calling for the administration to:
(1) ban the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP)– which were used in an estimated 67,500 surgical procedures 2 in the U.S. in 2010 — because these devices (a) offer no clinically significant benefits in comparison to surgical repairs for POP performed without placement of surgical mesh; and (b) have high rates of serious complications, many of which require additional surgical intervention and some of which are not amenable to surgical correction and result in permanent life-altering harm, therefore presenting “an unreasonable and substantial risk of illness or injury,” the standard for the FDA to institute proceedings to ban a device under the device law, 21 U.S.C. § 360f and 21 C.F.R. § 895.21(a);
(2) order all manufacturers of non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP to recall these products; and
(3) require that any non-absorbable surgical mesh product specifically designed and labeled for transvaginal repair of POP that is proposed for marketing in the future be classified as a class III device and be approved for marketing only under a premarket approval application (PMA) that includes data from well-designed, prospective clinical trials that provide a reasonable assurance that the surgical mesh product is safe and effective.
Please contact us for the latest transvaginal mesh lawsuit news if you suffered from problems after surgery.
